Multifunctional testing of PTCA catheters

New in vitro measuring methods for balloon catheters used for percutaneous transluminal coronary angioplasty (PTCA) and their verification in a comple x test device are presented. This system can mimic all relevant application situations. The central element of the test device is a coronary Vessel mo del matching the physiological situation in terms of geometrical structure and frictional properties. Reactive force sensors are used to measure the a pplication-relevant forces exerted by the catheter on the model vessel wall s and accessories, such as guide wire and guiding catheter. To generate a k ink-free advancement of the catheter and permit measurement of the active f orces, an alternating drive unit has been specially developed. The testing and application of the newly developed methods revealed statistically signi ficant differences between various types of catheter. The test device close s a gap between complex but subjective clinical tests, and individual objec tive, but application-removed in vitro test setups for PTCA catheters. Whil e the initial prototype had shortcomings with regard to the reproducibility of measurements, successor systems developed for industrial use are now in production. The properties of these measuring systems developed for the be nefit of manufacturer and reprocessor of PTCA catheters are discussed.